Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

University of Cincinnati

Status and phase: Completed; Phase 2

Conditions: Sternal Fracture; Rib Fracture; Blunt Chest Wall Trauma

Treatments: Drug: Liposomal bupivacaine; Drug: 0.9% sodium chloride

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02749968

Droege 2016

Details and patient eligibility

About

This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall trauma.

Full description

The purpose of this study is to evaluate the efficacy of liposomal bupivacaine to provide analgesia via paravertebral intercostal nerve block following significant blunt chest trauma, minimizing adverse outcomes, length of stay and overall narcotic use. The primary outcome of the study is to compare requirements between the bupivacaine group and a standard-of-care group.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Anticipated length of stay of at least 72 hours
• Blunt chest wall trauma with two or more rib or sternal fractures
• Demonstrated ability to achieve > 50% predicted inspiratory capacity based on ideal body weight using IS within the first 24 hours of admission

Exclusion criteria

• Known allergy to bupivacaine
• Respiratory failure requiring intubation within 24 hours prior to enrollment
• Known or suspected atrioventricular nodal blockade process requiring cardiology evaluation or pacemaker placement
• Hemodynamic instability (defined as new intravenous vasopressor or inotrope requirement or mean arterial pressure < 55 mmHg)
• Signs of active myocardial ischemia or non-ST elevation MI
• > 20 rib fractures
• Weight < 50 kg or > 150 kg
• Pregnancy
• Incarceration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Liposomal bupivacaine

Active Comparator group

Description:

1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position

Treatment:

Drug: Liposomal bupivacaine

0.9% sodium chloride

Placebo Comparator group

Description:

1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position

Treatment:

Drug: 0.9% sodium chloride